Even in Western health care systems, most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for specialists, (b) long travel distances to specialists, particularly in rural and remote areas, (c) patients' reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to measure the effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. In an individually randomized, prospective, two-arm superiority study with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in GP practices.
The purpose of this study is to measure the effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. In total, the investigators plan to enrol 320 patients who will be randomly allocated to the experimental condition (mental health specialist video consultations) or the control condition (treatment as usual from their GP) in a 1:1 ratio. General practitioners will recruit patients during their regular clinic hours. If the patient is interested in participation, the patient will receive the informed consent form and the baseline questionnaire from the GP. The practice team will send the patient's contact details to the study team who will screen the patient with respect to the eligibility criteria. Patients will be randomly allocated to one of the two study conditions (video consultation model vs. treatment-as-usual, TAU) in a 1:1 ratio by central randomisation. The evaluation of the primary outcome will be performed according to the intention-to-treat principle. The health economic evaluation will be carried out from the perspective of society. A cost-effectiveness and a cost-utility analysis will be carried out.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
376
The consultations will be based on a psychodynamic understanding with a solution-oriented stance and will follow a manual: Session 1: Getting familiar with the telemental health setting, building a working alliance and deepening diagnostics. Session 2: Clarification of the task/objective, focus building, motivational interviewing if necessary. Session 3-4: Focused brief interventions e.g. psychoeducation, promotion of social resources, activation of health-promoting lifestyles (sleep hygiene, eating diary, relaxation etc.), work on personal problems and, if necessary, initiation of further specialised treatment. Session 5: Ending the intervention, stabilisation, subsequent treatment plan and communicating a case summary to the general practitioner
Heidelberg University
Heidelberg, Baden-Wurttemberg, Germany
The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)
composite measure of depression and anxiety (range: 0-48 Points, higher score indicates more severly depressed/anxious)
Time frame: 6 months after inclusion
The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)
composite measure of depression and anxiety (range: 0-48 Points, higher score indicates more severly depressed/anxious)
Time frame: 12 months after inclusion
The Patient Health Questionnaire (PHQ-9)
depressive symptom severity (range: 0-27 Points, higher score indicates more severly depressed)
Time frame: 6 months after inclusion, 12 months after inclusion
Generalized Anxiety Disorder Scale (GAD-7)
anxiety symptom severity, range: 0-21, higher score indicates worse outcome
Time frame: 6 months after inclusion, 12 months after inclusion
Short-Form Health Survey 12 (SF-12)
health related quality of life (two dimensions: physical and mental quality of life, ranges: 0-100, higher score indicates higher quality of life
Time frame: 6 months after inclusion, 12 months after inclusion
Recovery Assessment Scale (RAS-G)
self-reported mental health recovery, five dimension: 1) Goal and success orientation, 2) No domination by Symptoms, 3) Personal confidence and hope, 4) Reliance on others, 5) Willingness to ask others for help, ranges 1-5, higher score indicates better outcome
Time frame: 6 months after inclusion, 12 months after inclusion
Somatic Symptom Disorder-B Criteria Scale (SSD-12)
self-reported somatisation, range: 0-48, higher score indicates worse outcome
Time frame: 6 months after inclusion, 12 months after inclusion
Patient Assessment of Chronic Illness Care (PACIC)
patients' satisfaction with the care of their chronic disease, range: 1-5, higher score indicates higher satisfaction
Time frame: 6 months after inclusion, 12 months after inclusion
EQ-5D
health related quality of life for health economic Evaluations, 5 dimensions: 1) Mobility, 2) Self-Care, 3) Usual Activities, 4) Pain/Discomfort, 5)Anxiety/Depression
Time frame: 6 months after inclusion, 12 months after inclusion
Questionnaire for the Assessment of Medical and non Medical Resource Utilisation in Mental Disorders (FIMPsy)
self reported use of medical and psychosocial services for health-economic evaluation
Time frame: 6 months after inclusion, 12 months after inclusion
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